RECRUITING

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

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Conditions

Breast Cancer SurvivorCancer Related Cognitive DifficultiesSleepQuality of Lifebreast cancerbrain fogprolonged nightly fastingnationwideremotenon-invasivehealth education

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

Official Title

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)

Quick Facts

Study Start:2025-03-18
Study Completion:2026-03-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06938555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 years old
  2. 2. diagnosed with breast cancer (all stages included)
  3. 3. ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
  4. 4. score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
  5. 5. able to speak/understand English
  6. 6. have access to a computer and Wi-Fi
  7. 7. live within the United States
  8. 8. Identifies as female
  9. 9. willing and able to fully participate in the study
  1. 1. type 1 diabetes
  2. 2. actively enrolled in formal diet/weight loss program
  3. 3. previous bariatric surgery
  4. 4. eating disorder history
  5. 5. night shift work
  6. 6. pregnant, breast feeding, or trying to get pregnant
  7. 7. dementia, psychological, psychiatric, or neurological diagnoses
  8. 8. active brain or central nervous system disease
  9. 9. prior or current use of memory enhancing medications
  10. 10. history or current brain radiation
  11. 11. frequently fasting for 12+ hours every night

Contacts and Locations

Study Contact

Jen Project Coordinator
CONTACT
602-496-8248
restorestudy@asu.edu
Dorothy Sears, PhD
CONTACT
602-496-3351
Dorothy.Sears@asu.edu

Principal Investigator

Dorothy Sears, PhD
PRINCIPAL_INVESTIGATOR
Arizona State University
Sarah James, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Arizona State University
Phoenix, Arizona, 85004
United States

Collaborators and Investigators

Sponsor: Arizona State University

  • Dorothy Sears, PhD, PRINCIPAL_INVESTIGATOR, Arizona State University
  • Sarah James, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2026-03-20

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2026-03-20

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • breast cancer survivor
  • brain fog
  • prolonged nightly fasting
  • nationwide
  • remote
  • non-invasive
  • health education
  • sleep
  • quality of life

Additional Relevant MeSH Terms

  • Breast Cancer Survivor
  • Cancer Related Cognitive Difficulties
  • Sleep
  • Quality of Life